Brief Title
Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia
Official Title
Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Brief Summary
The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H
antibody in the treatment of lymphoplasmacytic lymphoma.
Detailed Description
- Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient
tolerates these three test doses, then they will receive a total of 6 weeks of
Campath-1H therapy three times a week.
- After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose
they will be re-assessed by blood testing. If it is determined that their disease has
progressed in the period of time while the patient was on Campath-1H, the patient will
be removed from the study.
- If it is determined that the patient has achieved a complete remission after 6 weeks of
Campath-1H treatment a bone marrow biopsy will be performed to confirm complete
remission and the patient will not receive any additional treatment but will be followed
for a period of 2 years.
- If the disease has remained stable or partial response has been achieved the patient
will enter the second phase of therapy in which they will receive an additional 6 weeks
of Campath-1H therapy. The patient will then be reassessed as described above.
- No additional therapy (as part of this study) will be performed after a 12 week course
of Campath-1H.
- While the patient is on Campath-1H blood test will be performed at 3-6 month intervals
over a period extending for 2 years following the last treatment. Bone marrow biopsies
and/or aspirations will be conducted as necessary.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
Secondary Outcome
To determine the safety of Campath-1H.
Condition
Lymphoplasmacytic Lymphoma
Intervention
Campath-1H
Study Arms / Comparison Groups
Campath-1H
Description: 30 mg IV three times a week, 6-12 weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
March 2003
Completion Date
June 2008
Primary Completion Date
October 2005
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's
macroglobulinemia
- Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum
total bilirubin and SGOT < 2.5 times the upper normal limit.
- Age greater than 18 years
- Life expectancy of 6 months or greater
- ECOG performance status of 0-2
Exclusion Criteria:
- Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
- Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
- Pregnant women
- Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Steven P. Treon, MD, MA, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00142181
Organization ID
02-079
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
Study Sponsor
Steven P. Treon, MD, MA, PhD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
December 2012